证券代码：688062 证券简称：迈威生物 公告编号：2025-080 迈威（上海）生物科技股份有限公司 关于非独立董事辞任暨选举职工代表董事的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 重要内容提示： 迈威（上海）生物科技股份有限公司（以下简称"公司"）董事会于 2025 年 12 月 25 日收到非独立董事桂勋先生的书面辞任报告，因公司治理结构调整， 桂勋先生申请辞去第二届董事会非独立董事职务。除辞任非独立董事职务外，桂 勋先生在公司担任的其他职务不变。 公司于 2025 年 12 月 25 日召开第一届工会委员会第六次会员代表大会暨 职工代表大会，同意选举桂勋先生为第二届董事会职工代表董事，与其他在任董 事共同组成公司第二届董事会。任期自本次会员代表大会选举之日起至公司第二 届董事会任期届满之日止。 1 板股票上市规则》《上海证券交易所科创板上市公司自律监管指引第 1 号——规 范运作》等法律法规、规范性文件的相关规定。 一、董事离任情况 （一）提前离任的基本情况 | 姓名 | 离任 | 离任时间 | | ...

证券代码：688062 证券简称：迈威生物 公告编号：2025-079 迈威（上海）生物科技股份有限公司 2025年第三次临时股东大会决议公告 本公司董事会及全体董事保证公告内容不存在任何虚假记载、误导性陈述或 者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 重要内容提示： 本次会议是否有被否决议案：无 一、 会议召开和出席情况 （一） 股东大会召开的时间：2025 年 12 月 25 日 （二） 股东大会召开的地点：上海市浦东新区李冰路 576 号创想园 3 号楼 103 会议室 （三） 出席会议的普通股股东、特别表决权股东、恢复表决权的优先股股东及 其持有表决权数量的情况： | 1、出席会议的股东和代理人人数 | 151 | | --- | --- | | 普通股股东人数 | 151 | | 2、出席会议的股东所持有的表决权数量 | 205,835,818 | | 普通股股东所持有表决权数量 | 205,835,818 | | 3、出席会议的股东所持有表决权数量占公司表决权数量的比 | 51.5104 | | 例（%） | | | 普通股股东所持有表决权数量占公司表决权数量的比例（%） ...

北京植德（上海）律师事务所 关于迈威（上海）生物科技股份有限公司 2025 年第三次临时股东大会的 法律意见书 植德沪（会）字[2025]0058 号 二〇二五年十二月 上海市徐汇区虹桥路 183 号徐家汇中心三期 A 座办公楼 27 层（THREE itc） 邮编：200030 27th Floor Tower A, THREE itc, No.183 Hongqiao Road, Xuhui District, Shanghai 200030 P.R.C 电话(Tel)：021-52533500 传真(Fax)：021-52533599 www.meritsandtree.com 北京植德（上海）律师事务所 关于迈威（上海）生物科技股份有限公司 2025 年第三次临时股东大会的 法律意见书 植德沪（会）字[2025]0058 号 致：迈威（上海）生物科技股份有限公司（贵公司） 本所律师参加本次会议进行见证，并根据《中华人民共和国公司法》（以下 简称"《公司法》"）、《中华人民共和国证券法》（以下简称"《证券法》"）、 《上市公司股东会规则》（以下简称"《股东会规则》"）、《律师事务所从事 证券法律业务管理 ...

Group 1 - The core viewpoint of the news is that Maiwei Biotechnology has shown significant trading activity and financial performance, with a notable increase in revenue and changes in shareholder composition [1][2]. Group 2 - On December 24, Maiwei Biotechnology's stock rose by 0.99%, with a trading volume of 214 million yuan. The financing buy-in amount was 16.18 million yuan, while the financing repayment was 13.98 million yuan, resulting in a net financing buy-in of 2.20 million yuan. The total financing and securities balance reached 552 million yuan [1]. - The financing balance of Maiwei Biotechnology is 552 million yuan, accounting for 6.79% of its market capitalization, which is above the 60th percentile level over the past year, indicating a high level of financing [1]. - On the same day, the company had no shares repaid in securities lending, with 200 shares sold, amounting to 7,968 yuan. The securities lending balance was 325,600 yuan, which is below the 30th percentile level over the past year, indicating a low level of securities lending [1]. - As of September 30, the number of shareholders of Maiwei Biotechnology was 19,600, an increase of 9.15% from the previous period. The average circulating shares per person decreased by 8.38% to 10,425 shares [2]. - For the period from January to September 2025, Maiwei Biotechnology achieved operating revenue of 566 million yuan, a year-on-year increase of 301.03%. However, the net profit attributable to the parent company was -598 million yuan, reflecting a year-on-year increase of 13.89% [2]. - Among the top ten circulating shareholders as of September 30, 2025, E Fund Medical Healthcare Industry Mixed A ranked as the fourth largest shareholder with 3.17 million shares, marking a new entry. Hong Kong Central Clearing Limited ranked sixth with 2.87 million shares, a decrease of 1.87 million shares from the previous period. Southern CSI 1000 ETF ranked ninth with 2.19 million shares, also a new entry [2].

Core Viewpoint - Maiwei Biotech announced that it received a Clinical Study Continuation Notification from the FDA, allowing the clinical research of 9MW1911 to proceed as planned, focusing on its pharmacokinetics, safety, tolerability, and preliminary efficacy in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) participants [1] Group 1 - The FDA has approved the continuation of the clinical study for 9MW1911, which is a randomized, double-blind, placebo-controlled Phase IIa clinical trial [1] - 9MW1911 is an innovative monoclonal antibody developed based on a high-efficiency B lymphocyte screening platform, classified as a Class I therapeutic biological product [1] - The drug targets the ST2 receptor to block the IL33/ST2 signaling pathway and is currently advancing rapidly in Phase II clinical research in China, having completed the Phase IIa clinical study in COPD patients [1]

Core Viewpoint - Maiwei Biotech (688062.SH) has completed a share buyback, acquiring a total of 1,192,369 shares, which represents 0.30% of the company's total share capital [1] Summary by Categories Share Buyback Details - The maximum buyback price was 58.02 CNY per share, while the minimum price was 37.48 CNY per share [1] - The average buyback price was 41.93 CNY per share [1] - The total amount of funds used for the buyback was 49.9945 million CNY, excluding transaction fees such as stamp duty and commission [1]

Core Viewpoint - Maiwei Biotech (688062) has received FDA approval for its clinical trial application for 9MW1911 injection, allowing the company to proceed with a Phase IIa clinical study to evaluate the pharmacokinetics, safety, tolerability, and preliminary efficacy of 9MW1911 in participants with moderate to severe chronic obstructive pulmonary disease (COPD) [1] Group 1 - The FDA issued a "Notice of Continuation of Clinical Research" for Maiwei Biotech on December 23 [1] - The clinical study will be randomized, double-blind, and placebo-controlled [1] - The focus of the study is on participants with moderate to severe COPD [1]

Core Viewpoint - Maiwei Biotech (688062.SH) has received a Study May Proceed Notification from the FDA, allowing the clinical trial application for 9MW1911 to proceed [1] Group 1: Company Information - 9MW1911 is an innovative monoclonal antibody developed based on a high-efficiency B lymphocyte screening platform [1] - The product is classified as a Class 1 therapeutic biological product [1] - 9MW1911 has a high affinity for the ST2 receptor, which blocks the IL33/ST2 signaling pathway [1]

9MW1911为一款基于高效B淋巴细胞筛选平台自主研发的创新单克隆抗体，属于治疗用生物制品1类， 可高亲和力结合ST2受体，从而阻断IL33/ST2 信号通路。 智通财经APP讯，迈威生物(688062.SH)发布公告，近日，公司收到美国食品药品监督管理局(FDA)签发 的《临床研究继续进行通知书》(Study May Proceed Notification)，9MW1911注射液临床试验申请正式获 得FDA许可。 ...

证券代码：688062 证券简称：迈威生物 公告编号：2025-077 迈威（上海）生物科技股份有限公司 自愿披露关于 9MW1911 注射液临床试验申请 获得 FDA 许可的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 重要内容提示： 近日，迈威（上海）生物科技股份有限公司（以下简称"迈威生物"或"公 司"）收到美国食品药品监督管理局（FDA）签发的《临床研究继续进行通知书》 （Study May Proceed Notification），9MW1911 注射液临床试验申请正式获得 FDA 许可。由于药品的研发周期长、审批环节多，容易受到一些不确定性因素的影响， 敬请广大投资者谨慎决策，注意防范投资风险。现将相关情况公告如下： 一、药品基本情况 药品名称：9MW1911 注射液 申请号：IND 177824 申请人：迈威（上海）生物科技股份有限公司 审批结论：FDA 已完成对本次申请的安全性评估，同意本品按照拟定的临床 研究计划开展，即"以评估 9MW1911 在中重度慢性阻塞性肺疾病（COPD）参与 者中的药 ...